Full Conformity Assessment
Conformity assessment is a systematic and ongoing examination of evidence and procedures to ensure the safety, performance, benefit and risk of medical devices. It is also to ensure manufacturing compliance to essential principles of safety and performance (EPSP) and requirements of the Medical Device Act 2012 (Act 737). The classification of a medical device determines the conformity assessment procedures to be undertaken. Conformity assessment becomes more stringent as the risk of medical device increases.
The establishments need to determine their medical devices classification using Appendix I in Medical Device Regulations 2012 which are Class A, Class B, Class C or Class D. For submission of medical device registration, the establishments also need to prepare the technical file for each medical including Quality Management System, Post Market and Surveillance, technical documentation such as Common Submission Dossier Template (CSDT), and Declaration of Conformity (DoC)
Conformity Assessment by Way of Verification
The verification of evidence of conformity of medical device shall be done only for medical device approved by recognised foreign regulatory authority or notified body which are Therapeutic Goods Administration (TGA) Australia, Health Canada, Notified bodies listed in New Approach Notified and Designated Organisations (NANDO) database of European Union (EU), Ministry of Health, Labour and Welfare (MHLW) Japan and/or Food and Drug Administration (FDA) United States of America (USA). This verification process shall be done by registered CAB. Refer to Circular Letter of Medical Device Authority No. 2 Year 2014 Policy in Implementation and Enforcement Under the Medical Device Act 2012 (Act 737); Conformity Assessment Procedures for Medical Device Approved by Recognized Countries.